Panel Discussion: Biologics and Biosimilars: Challenges and opportunities in FDD

Panelists in this video:
+ Dr Shrikant Mishra, Professor & Head, Technology & Translation Laboratory, School of Biotechnology, KIIT University, Bhubaneshwar (Moderator)
+ Dr Jaby Jacob, Sr President – R&D, Bharat Serums & Vaccines
+ Dr Dinesh Kundu, Co-founder & CEO, QbD Biosciences
+ Jayant Gangakhedkar, Asst Drugs Controller (I), Biologicals Div, CDSCO
+ Dr Ramakrishna Bangaru, Sr VP, Clinical Pharmacology Research, Viatris (Formerly as Mylan)

Key Highlights:
● There has been a lot of progress in the field of biological and biosimilars in terms of drug delivery, for instance, micro needles, to improve patient-compliance: Dr Jaby Jacob, Sr President – R&D, Bharat Serums and Vaccines

● There are multiple stringent checks done at multiple levels, before regulatory approvals are given to biological and biosimilars in India: Jayant Gangakhedkar, Asst Drugs Controller Biologicals Division, CDSCO

● Indigenous manufacturers of biologics and biosimilars must generate data of minimum consecutive batches of their product to ensure quality, safety and efficacy: Jayant Gangakhedkar, Asst Drugs Controller Biologicals Division, CDSCO

● Be it cell and gene therapies or biologics approval, the pathways have been clear with elaborate checks in place. So, we are seeing double digit and triple digit numbers getting approved in US and Europe: Dr Dinesh Kundu, Co-founder & CEO, QbD Biosciences

● More than 670 development programmes have been initiated for COVID related treatments and vaccines in two years. Around 10-20 biologics have been approved in the last 15-20 years but over 470+ trials have been reviewed in 18 months: Dr Dinesh Kundu, Co-founder & CEO, QbD Biosciences

● Education, training and safety awareness are key to reduce recalls of biological and biosimilar drugs: Dr Shrikant Mishra, Professor and Head, Technology, and Translation Laboratory, School of Biotechnology, KIIT University

● Both, patients and pharma companies, end up paying the cost of errors and drug recalls. We need to improve input quality and ensure stringent checks across the development lifecycle: Dr Ramakrishna Bangaru, Sr VP, Clinical Pharmacology Research, Viatris